The following data is part of a premarket notification filed by Medacta International with the FDA for Gmk Revision Extension.
| Device ID | K123721 |
| 510k Number | K123721 |
| Device Name: | GMK REVISION EXTENSION |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | MEDACTA INTERNATIONAL 4725 Calle Quetzal, Unit B Camarillo, CA 93012 |
| Contact | Adam Gross |
| Correspondent | Adam Gross MEDACTA INTERNATIONAL 4725 Calle Quetzal, Unit B Camarillo, CA 93012 |
| Product Code | JWH |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-12-04 |
| Decision Date | 2013-07-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07630030819438 | K123721 | 000 |
| 07630030819339 | K123721 | 000 |
| 07630030819346 | K123721 | 000 |
| 07630030819353 | K123721 | 000 |
| 07630030819360 | K123721 | 000 |
| 07630030819377 | K123721 | 000 |
| 07630030819384 | K123721 | 000 |
| 07630030819391 | K123721 | 000 |
| 07630030819407 | K123721 | 000 |
| 07630030819414 | K123721 | 000 |
| 07630030819421 | K123721 | 000 |
| 07630030819322 | K123721 | 000 |